Operation Warp Speed was announced mid-way through May, which saw the US government promise to ready a vaccine against COVID-19 by the beginning of next year.
Since that time, the US has provided significant funds to develop potential candidates, as well as securing the additional materials required for delivery.
The largest funding yet was revealed yesterday, as Novovax was provided $1.6bn (€1.4bn) to complete a Phase III clinical trial, ready large-scale manufacturing and to deliver 100 million doses to the US.
According to the US Department of Health and Human Services (HHS), the doses would be made available for use in clinical trials or, should the vaccine be approved by US Food and Drug Administration (FDA), as part of the country’s COVID-19 vaccination program.
The terms of the agreement will require Novavax to demonstrate that it can manage large-scale manufacture of the vaccine and transition into ongoing production. In addition, the company will have to ensure that it is able to stockpile vaccine doses and distribute them in large quantities.
The vaccine candidate Novavax is working on is NVX-CoV2373, which was created using recombinant nanoparticle technology to generate antigen derived from the coronavirus spike protein, and utilizes a saponin-based ‘Matrix-M’ adjuvant.
Novavax plans to take the vaccine candidate into Phase III trials, including up to 30,000 recipients, beginning in the fall of this year. The funding for the trial will be derived from the $1.6bn delivered by the US government.
There is currently an ongoing Phase I/II study taking place in Australia that began in May and will have readouts by the end of this month. The results from this trial will inform the Phase II portion of the study.
The funding for this trial was supported by a $388m grant from the Coalition for Epidemic Preparedness Innovations (CEPI), part of which the company utilized to acquire Praha Vaccines and thereby boost its manufacturing capacity for its COVID-19 vaccine candidate.
Developing a COVID-19 arsenal
At the same time as the funding provided to Novavax, the US government also provided Regeneron $450m to support the production of its investigational antibody cocktail to treat the novel coronavirus.
The potential therapy, which is being tested as both a treatment and as a prevention against the virus, entered Phase III and Phase II/III trials earlier this week.
With REGN-COV2 entering late-stage trials, the US government provided the funding to help scale up the manufacture of the double antibody treatment and also to reserve 70,000 to 300,000 doses for its citizens.
According to the CEO of Berkeley Lights, the approval of a treatment for COVID-19 would be an important step on the pathway to ‘normality’, especially if made available prior to an approved vaccine.